Serious Game-based Intervention in Gait Rehabilitation for Children With

Status Recruiting

Clinical Trial Summary

Cerebral palsy (CP) is defined as a group of movement and posture disorders that cause activity limitation due to brain damage during fetal development or in the first year of life. Motor activities, and in particular walking, can be affected by many factors including sensory deficits, biomechanical and postural limitations, muscle weakness and spasticity. Theories of gait training guide rehabilitation management strategies. Among these, intensification, variability and specific training of walking parameters (speed, step length, cadence) have shown their effectiveness. Delivering sensory feedback during gait rehabilitation exercises is a complementary approach to improve motor learning during rehabilitation. On the other hand, motivation is a key factor in the success of rehabilitation. The addition of walking exercises performed through a serious game in augmented reality (AR) appears relevant for the rehabilitation of children with CP after surgery. The serious game ARRoW-CP is based on the latest advances in the literature in terms of gait rehabilitation protocol but also on the results of a clinical study conducted by our team, to identify the best feedback modalities to be delivered during the serious rehabilitation game.

Clinical Trial Description

This study is a randomized control trial. Participants are children with cerebral palsy having a single event multi level surgery. They are involving in a rehabilitation protocol in the same rehab center. Two groups are formed: - control group: classic rehab+children have treadmill gait protocol during 4 weeks - test group : classic rehab+children have gait training with the ARROW CP serious game. ARROW CP game is developed for augmented reality headset (Microsoft Hololens). It delivers feedback in real time and with delay on participant gait performance. This game has been developed by researchers (Fondation Ellen Poidatz, France). The aims of this study are: 1. . To determine the impact on spatiotemporal gait parameters of intensive gait rehabilitation involving the use of a serious AR game in children and adolescents with cerebral palsy. 2. To explore the effects of playing a serious game on functional abilities 3. To assess motivation, satisfaction and adherence to treatment ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04837105
Study type	Interventional
Source	Fondation Ellen Poidatz
Contact
Status	Recruiting
Phase	N/A
Start date	April 15, 2021
Completion date	December 31, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Serious Game-based Intervention in Gait Rehabilitation for Children With Cerebral Palsy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms